Immunizations

CSTE Comment - v5

CSTE agrees with CDC and continues to strongly recommends that Vaccine Administration Date and Vaccination Event Record Type be included in USCDI v5. Both elements are required for immunization exchange and always have been. Each year, IIS respond to CDC’s annual report (IISAR). At the end of calendar year 2019, IIS records contained vaccine administration date 99.9% of the time with only 1 IIS reporting less than 100%. With these lacking from USCDI v5 draft, it would be possible to list only the immunization code a patient received, but not the date the patient received the dose or if the vaccination event originated in the source system. Vaccine Administration Date enables accurate record evaluation (e.g., were doses given at the proper age and at a proper interval) while Vaccination Event Record Type enable accurate inventory decrementing by public health and aids in vaccine matching/deduplication.

CDC and CMS-CCSQ Joint Support for Vaccination Event Record Type

Thank you for opportunity to comment on this data element. The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) emphasize the importance of patient safety being reflected in the USCDI standards. Identification of whether vaccinations are current and whether any vaccinations need to be administered using the Vaccination Event Record Type and Immunization Status data elements are vital to patient safety outcomes. CMS and CDC strongly recommend the Vaccination Event Record Type (Level 2) data element in the Immunization data class be added to USCDI. This addition would promote patient safety.

CDC's comment on behalf of NACCHO for USCDI v5

Support - The standardization of this data element will enhance LHDs ability to use and analyze this data. It will reduce the data preparation burden and thus enable more LHDs to use this type of data to inform decision-making.

CDC's comment on behalf of CSTE for USCDI v5

CSTE agrees with CDC and continues to strongly recommends that Vaccine Administration Date and Vaccination Event Record Type be included in USCDI v5. Both elements are required for immunization exchange and always have been. Each year, IIS respond to CDC’s annual report (IISAR). At the end of calendar year 2019, IIS records contained vaccine administration date 99.9% of the time with only 1 IIS reporting less than 100%. With these lacking from USCDI v4 it would be possible to list only the immunization code a patient received, but not the date the patient received the dose or if the vaccination event originated in the source system. Vaccine Administration Date enables accurate record evaluation (e.g., were doses given at the proper age and at a proper interval) while Vaccination Event Record Type enable accurate inventory decrementing by public health and aids in vaccine matching/deduplication.

CDC's Consolidated Comment for USCDI v5

• The "Vaccination Event Record Type" is a proposed essential data element for inclusion in the v5 USCDI, designed to enhance the quality and consistency of immunization data management across healthcare systems. This data element allows for the standardized categorization of vaccine events, significantly contributing to data interoperability across disparate health information systems. DefiningDefining a consistent framework for categorizing vaccination events enables healthcare professionals to accurately determine when subsequent vaccinations should be administered, thereby promoting adherence to recommended vaccination schedules and improving patient care. This element is critical for resolving duplicate vaccination records, a common issue that can lead to patient safety concerns and administrative burdens. The "Vaccination Event Record Type" is also pivotal for public health management, enabling efficient, real-time tracking and monitoring of vaccination trends at a population level. This facilitates timely and informed responses to emerging vaccination patterns, vaccine uptake rates, and potential adverse events following immunization. For instance, in mass vaccination campaigns, such as those for influenza or COVID-19, having a standardized record type can streamline reporting, minimize errors, and ensure that vaccines are effectively distributed and administered based on actual need. Moreover, this data element can play a crucial role in research, supporting robust and high-quality data sets for vaccine effectiveness and safety analysis. Therefore, we strongly advocate for including the "Vaccination Event Record Type" in the USCDI v5 due to its potential to significantly elevate the standard of care, improve data accuracy and reliability, and empower robust public health surveillance and response mechanisms.

• ** ADD THIS USE CASE TO SUBMISSION **

1. "Immunizations HPV": HPV is estimated to cause 70% of oropharyngeal cancers in the United States, although it is unclear if having HPV alone is enough to cause oropharyngeal cancers, or if other factors interact with HPV to cause these cancers. Because the HPV vaccine protects against the types of HPV that can cause oropharyngeal cancers, it may also prevent oropharyngeal cancers. The United States is struggling to achieve HPV vaccination goals because HPV vaccination policies vary greatly nationwide, making it hard to implement sustainable programs. Surveillance of HPV vaccination and risk factors can help to establish associations, identify at-risk populations, and better inform clinical decision-making guidelines and interventions. These activities can increase vaccination acceptance rates and may lower HPV-associated oropharyngeal cancer prevalence and incidence.

CMS-CCSQ/CDC Joint USCDIv4 Priority Vacc. Event Record Type

The immunization data element provides critical information about whether a vaccination has ever been administered, planned or reported. The current immunization data element is insufficient to identify whether the vaccination is based on the historical record or was administered at the facility submitting the vaccine. By adding vaccine event record type for immunizations, ONC can also ensure data elements necessary to determine whether vaccinations are current, and whether any vaccinations need to be administered.

CMS-CCSQ Support for Vaccination Event Record Type: USCDI v4

The immunization data element provides critical information about whether a vaccination has ever been administered, planned or reported. The current immunization data element is insufficient to identify whether the vaccination is based on the historical record or was administered at the facility submitting the vaccine. By adding vaccine event record type for immunizations, ONC can also ensure data elements necessary to determine whether vaccinations are current, and whether any vaccinations need to be administered. Vaccine efficacy analyses use this information to determine immunization population coverage. Statistical analyses help to identify underserved populations so that resources are redirected appropriately and used efficiently. This should not add any substantial burden on vendors or implementers, as this metadata should already be routinely captured. As this information helps improve accuracy of vaccine reporting, it can benefit many existing CMS vaccination quality measures.

Maturity: This data element is classified as Level 2 by ONC and continues to have strong standardization and be in wide use.

• Current standards:
  • https://phinvads.cdc.gov/vads/ViewCodeSystem.action?id=2.16.840.1.114222.4.5.293 HL7 v2.5.1 and 2.8.2 Implementation Guides: https://www.cdc.gov/vaccines/programs/iis/technical-guidance/hl7.html

Current uses, exchange, and use cases: The vaccination event record type data element provides information that is currently lacking in the USCDI on timing of the immunizations that can improve accuracy of measurement. Immunization information may not directly provide disparity information, but it is needed together with other disparity-related data (e.g., race, ethnicity, location) to identify vaccine breakthroughs or problems with vaccination access/coverage which may also speak to broader health disparities related to general access to medical care and services. This data is particularly important for COVID-19 reporting. This data element also allows CDC to see where immunizations may be lacking and can support future CMS quality measure reporting.

CDC's Consolidated Comment for USCDI v4

CDC continues to recommend inclusion of this high priority data element in USCDI v4

CSTE Comment:

• CSTE agrees with CDC and continues to strongly recommends that Vaccine Administration Date and Vaccination Event Record Type be included in USCDI v4. Both elements are required for immunization exchange and always have been. Each year, IIS respond to CDC’s annual report (IISAR). At the end of calendar year 2019, IIS records contained vaccine administration date 99.9% of the time with only 1 IIS reporting less than 100%. With these lacking from USCDI v4 it would be possible to list only the immunization code a patient received, but not the date the patient received the dose or if the vaccination event originated in the source system. Vaccine Administration Date enables accurate record evaluation (e.g., were doses given at the proper age and at a proper interval) while Vaccination Event Record Type enable accurate inventory decrementing by public health and aids in vaccine matching/deduplication.

Unified Comment from CDC

• Additional Use Case: Immunization information including date of administration is collected as part of case based surveillance for Hepatitis A, Acute Hepatitis B and Perinatal Hepatitis B to understand hepatitis transmission patterns and ensure appropriate interventions are prioritized within impacted communities.
   
• Additional Use Cases: Immunization elements are a major piece of public health control and mitigation. When combined with case reports to a jurisdiction or notification to CDC, it allows the jurisdiction or CDC to see where immunizations may be lacking. Immunization information may not directly provide disparity information, but it is needed together with other disparity-related data (e.g., race, ethnicity, location) to identify vaccine breakthroughs or problems with vaccination access/coverage which may also speak to broader health disparities related to general access to medical care and services.
   
• Estimate number of stakeholders who capture, access, use or exchange this data element: All US States and DC are funded through CDC’s Division of Viral Hepatitis flagship Notice of Funding Actions to perform surveillance activities, including collection of these data for surveillance purposes.
   
• Healthcare Aims:
• 1. Improving patient experience of care
• 2. Improving health of populations
• 3. Reducing cost of care
• 4. Improving provider experience of care
   
• Use of data element: Extensively used in production environments
   
• CSTE supports inclusion of this measure into USCDI v3: supports information being shared with IIS across the country – should be captured for all IZ, not just children